1. Field of the Invention
The present invention relates generally to dilatation devices. More particularly, the invention concerns a wound dilatation device for controlling internal blood loss from defined deep puncture wounds immediately following traumatic injury.
2. Discussion of the Invention
The incidence of accidents requiring emergency trauma care is large and growing. Each year in the United States, 1 in 4 Americans sustain an injury requiring medical treatment. Health care costs for treating injuries was $158 billion in 1985, and is estimated to exceed $1 trillion in 1993. Injuries are the leading cause of death for Americans aged 1 to 44 years exceeding cancer, heart disease and AIDS. The rate of hospitalization due to injuries is 15 to 20 per 1,000 population for ages 20 to 40 and over 60 years, and overall represents 3.58 million Americans per year. Approximately 4.3% of all injuries requiring hospitalization result in death.
As a general rule paramedics or emergency practitioners treat and attempt to stabilize injured patients in the field, prior to their transport to hospitals for emergency surgery or trauma care. The treatment provided by these primary care givers has a significant influence on the eventual survival and long-term health for these patients. The presence of vital signs and consciousness in trauma patients arriving at the emergency room is strongly correlated with a higher incidence of survival and lack of long-term complications.
Two common injuries routinely encountered in the emergency room and by paramedics in the field are deep puncture wounds generally caused by gunshots and stabs. The seriousness of these problems is amplified by the fact that there are about 21,000 deaths every year in the United States as a result of gunshot and stab wounds. In most cases, gunshot wounds are caused by small caliper hand guns and stabs are caused by pocket knives, leaving small localized areas of heavy trauma. Deep wound injuries also occur as a result of automobile and occupational-type injuries. In these type of injuries, the victims typically go into shock and lose significant quantities of blood within minutes of the injury and many die before they can be transported to a hospital for repair surgery. However, statistics clearly show that patients that survive the initial injury and repair surgery usually have a good prognosis for recovery.
At the present time, paramedics have no suitable means for effectively controlling internal bleeding and trauma from deep puncture wounds. Normal practice is to replace fluids and electrolytes with IV solutions, irrigate and dress external wound sites, and give drugs to stabilize vital signs. Such practice is seriously ineffective in many instances.
A major challenge in stabilizing the deep wound patient is managing the rapid loss of blood, the mixing of different body fluids (e.g. blood, GI contents, bile, lymph) in the peritoneal cavity, and the retention of replacement fluids in the bloodstream to correct hypovolemia. Definitive care must be provided to severely bleeding patients with deep wounds within 30 minutes after injury. Blood losses exceeding 30% of a patient's total blood volume are associated with shock and hypotension.
The current practice in stabilizing wounds involves On-site Advanced Life Support (ALS) procedures comprising intubation, applying external pressure to arrest bleeding, packing and/or dressing with gauze, intravenous line initiation and fluid replacement, and the use of pneumatic antishock garments (PASG).
Current ALS procedures are inadequate for managing deep wounds and have no effect on patient survival. Patients continue to bleed and lose replacement fluids after ALS, since most deep wounds involve internal bleeding which ALS cannot alleviate. Failure to stabilize patients within one hour after injury (e.g., the "Golden Hour") results in reduced survival and long-term morbidity. Even if partial stabilization occurs, shock caused by blood loss, organ perforation and drainage, adversely affects patient outcome.
Therefore, there exists a need for improved interventional methods and specialized medical equipment to rapidly stabilize and reach hemostasis in patients with deep trauma wounds, beginning in the field and continuing until surgical repairs have been completed or a patient is stable in post-op. More specifically, there exists a need to effectively arrest blood loss from a deep trauma wound as early as possible after injury, and to restore near normal tissue perfusion and oxygenation to the patient through fluid replacement, prior to transport to the emergency room or operating room. The thrust of the present invention is to respond to this need by providing the care giver with a device that is easy to use in the field and effectively arrests blood loss in a very short period of time.